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Rule: Byproduct material; domestic licensing: Licensing exemptions, general licensing and reporting requirements

Rule: Byproduct material; domestic licensing: Licensing exemptions, general licensing and reporting requirements

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Rule: Byproduct material; domestic licensing:
Licensing exemptions, general licensing and reporting requirements, 58473-58489 [E7-19944] Nuclear Regulatory Commission
Rule: Byproduct material; domestic licensing:
Licensing exemptions, general licensing and reporting requirements, 58473-58489 [E7-19944] Nuclear Regulatory Commission

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Published by: Justia.com on May 01, 2008
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Federal Register/ Vol. 72, No. 199 / Tuesday, October 16, 2007 / Rules and Regulations

considered that in the absence of an
initial recommendation from the NOSB
to permit the addition of nonsynthetic
colors as a broad category that they
could not continue to permit the
exemption of nonsynthetic colors on

\u00a7205.605(a). As a result, the NOSB
voted not to renew the exemption of
nonsynthetic colors on\u00a7 205.605(a).
F. Effective Date

This final rule reflects
recommendations submitted to the
Secretary by the NOSB for the purpose
of fulfilling the requirements of 7 U.S.C.
6517(e) of the OFPA. 7 U.S.C. 6517(e)
requires the NOSB to review each
substance on the National List within 5
years of its publication. The substances
being reauthorized for use on the
National List were initially authorized
for use or prohibition in organic
agriculture on October 21, 2002.
Because these substances are critical to
organic production and handling
operations, producers and handlers
should be able to continue to use them
beyond their 5-year expiration date of
October 21, 2007. Accordingly, this rule
shall be effective on October 21, 2007.

List of Subjects in 7 CFR Part 205

Administrative practice and
procedure, Agriculture, Animals,
Archives and records, Imports, Labeling,
Organically produced products, Plants,
Reporting and recordkeeping
requirements, Seals and insignia, Soil

IFor the reasons set forth in the
preamble, 7 CFR part 205, Subpart G is
amended as follows:
I1. The authority citation for 7 CFR
part 205 continues to read as follows:
Authority: 7 U.S.C. 6501\u20136522.
I2. Section 205.603 is revised to read
as follows:
\u00a7205.603 Synthetic substances allowed
for use in organic livestock production.

In accordance with restrictions
specified in this section the following
synthetic substances may be used in
organic livestock production:

(a) As disinfectants, sanitizer, and

medical treatments as applicable.
(1) Alcohols.
(i) Ethanol-disinfectant and sanitizer

only, prohibited as a feed additive.
(ii) Isopropanol-disinfectant only.
(2) Aspirin-approved for health care

use to reduce inflammation.
(3) Biologics\u2014vaccines.
(4) Chlorhexidine\u2014allowed for

surgical procedures conducted by a

veterinarian. Allowed for use as a teat
dip when alternative germicidal agents
and/or physical barriers have lost their

(5) Chlorine materials\u2014disinfecting
and sanitizing facilities and equipment.
Residual chlorine levels in the water
shall not exceed the maximum residual
disinfectant limit under the Safe

Drinking Water Act.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
(6) Electrolytes\u2014without antibiotics.
(7) Glucose.
(8) Glycerine\u2014allowed as a livestock

teat dip, must be produced through the

hydrolysis of fats or oils.
(9) Hydrogen peroxide.
(10) Iodine.
(11) Magnesium sulfate.
(12) Oxytocin\u2014use in postparturition

therapeutic applications.

(13) Paraciticides. Ivermectin-
prohibited in slaughter stock, allowed in
emergency treatment for dairy and
breeder stock when organic system
plan-approved preventive management
does not prevent infestation. Milk or
milk products from a treated animal
cannot be labeled as provided for in
subpart D of this part for 90 days
following treatment. In breeder stock,
treatment cannot occur during the last
third of gestation if the progeny will be
sold as organic and must not be used
during the lactation period for breeding

(14) Phosphoric acid\u2014allowed as an
equipment cleaner,Provided, That, no
direct contact with organically managed
livestock or land occurs.

(b) As topical treatment, external
parasiticide or local anesthetic as

(1) Copper sulfate.
(2) Iodine.

(3) Lidocaine\u2014as a local anesthetic.
Use requires a withdrawal period of 90
days after administering to livestock
intended for slaughter and 7 days after
administering to dairy animals.

(4) Lime, hydrated\u2014as an external
pest control, not permitted to cauterize
physical alterations or deodorize animal

(5) Mineral oil\u2014for topical use and as
a lubricant.

(6) Procaine\u2014as a local anesthetic,
use requires a withdrawal period of 90
days after administering to livestock
intended for slaughter and 7 days after
administering to dairy animals.

(c) As feed supplements. None.
(d) As feed additives.

(1) DL\u2013Methionine, DL\u2013Methionine-
hydroxy analog, and DL\u2013Methionine-
hydroxy analog calcium (CAS #59\u201351\u2013
8; 63\u201368\u20133; 348\u201367\u20134) for use only in

organic poultry production until
October 21, 2008.

(2) Trace minerals, used for
enrichment or fortification when FDA

(3) Vitamins, used for enrichment or
fortification when FDA approved.

(e) As synthetic inert ingredients as
classified by the Environmental
Protection Agency (EPA), for use with
nonsynthetic substances or a synthetic
substances listed in this section and
used as an active pesticide ingredient in
accordance with any limitations on the
use of such substances.

(1) EPA List 4\u2014Inerts of Minimal

(2) [Reserved]
(f)\u2013(z) [Reserved]

\u00a7205.605 [Amended]
I3. In\u00a7 205.605, substances\u2018\u2018colors,
nonsynthetic sources only\u2019\u2019 is removed
from paragraph (a) and the substance
\u2018\u2018Potassium tartrate made from tartaric
acid\u2019\u2019 is removed from paragraph (b).
Dated: October 10, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing
[FR Doc. E7\u201320326 Filed 10\u201315\u201307; 8:45 am]
BILLING CODE 3410\u201302\u2013P
10 CFR Parts 30, 31, 32, and 150
RIN 3150\u2013AH41

Exemptions From Licensing, General
Licenses, and Distribution of
Byproduct Material: Licensing and
Reporting Requirements

AGENCY: Nuclear Regulatory
ACTION: Final rule.
SUMMARY: The U.S. Nuclear Regulatory

Commission (NRC) is amending several
regulations governing the distribution of
byproduct material. The reporting
requirements for licensees distributing
byproduct material to persons exempt
from licensing are being changed,
obsolete provisions are being deleted,
certain regulatory provisions are being
clarified, and smoke detector
distribution regulations are being
simplified. In addition, this final rule
modifies the process for transferring a
generally licensed device for use under
a specific license. Aspects of this rule
will affect distributors of exempt
byproduct material, some general
licensees, and some users of exempt
products. These actions are intended to

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Federal Register/ Vol. 72, No. 199 / Tuesday, October 16, 2007 / Rules and Regulations
1NUREG\u20131717 is a historical document

developed using the models and methodology
available in the 1990s. The NUREG provides the
estimate of the radiological impacts of the various
exemptions from licensing based on what was
known about distribution of material under the
exemptions in the early 1990s. NUREG\u20131717 was
used as the initial basis for evaluating the
regulations for exemptions from licensing
requirements and determining whether those
regulations adequately ensured that the health and
safety of the public were protected consistent with
NRC policies related to radiation protection. The
agency will not use the results presented in
NUREG\u20131717 as a sole basis for any regulatory
decisions or future rulemaking without additional

Copies of NUREGs may be purchased from the
Superintendent of Documents, U.S. Government
Printing Office, P.O. Box 37082, Washington, DC
20013\u20137082. Copies are also available from the
National Technical Information Service, 5285 Port
Royal Road, Springfield, VA 22161. A copy is also
available for inspection and/or copying for a fee at
the NRC public Document Room, One White Flint
North, 11555 Rockville Pike, Public File Area O1\u2013
F21, Rockville, MD.

make the licensing of distribution to
exempt persons more effective and
efficient, reduce unnecessary regulatory
burden to certain general licensees, and
better ensure the protection of public
health and safety.

DATES:Effective Date: This final rule is
effective on December 17, 2007.

Andy Imboden, Office of Federal and
State Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555\u20130001, (301) 415\u20132327,


I. Background
A. Introduction
B. Regulatory Framework

II. Discussion

A. Improved Reporting of Distribution to
Persons Exempt From Licensing

B. NRC Licensing of the Introduction of

Exempt Concentrations
C. Bundling of Exempt Quantities
D. Obsolete Provisions
E. New Product-Specific Exemption for

Smoke Detectors
F. Specific Licenses and Generally
Licensed Devices\u2014Clarification
III. Summary of Public Comments on the
Proposed Rule
A. Meaning of the Term\u2018\u2018Byproduct

B. Exempt Quantity Distribution Reports
C. Transfer of Generally Licensed Devices
D. New Product-Specific Exemption for

Smoke Detectors
E. NRC\u2014Agreement State Jurisdictional
F. Disposal of Exempt and Generally

Licensed Devices
IV. Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Voluntary Consensus Standards
VIII. Environmental Assessment and Finding

of No Significant Environmental Impact:

IX. Paperwork Reduction Act Statement
X. Regulatory Analysis
XI. Regulatory Flexibility Certification
XII. Backfit Analysis
XIII. Congressional Review Act

I. Background
A. Introduction

The Commission has authority to
issue both specific and general licenses
for the use of byproduct material, and
also to exempt byproduct material from
regulatory control under section 81 of
the Atomic Energy Act of 1954, as
amended (hereafter,\u2018\u2018the Act\u2019\u2019 or the
AEA). In considering its exemptions
from licensing, the Commission is
directed by the Act to make\u2018\u2018a finding
that the exemption of such classes or
quantities of such material or such
kinds of uses or users will not constitute

an unreasonable risk to the common
defense and security and to the health
and safety of the public.\u2019\u2019 To ensure that
its exemptions meet the requirements of
the Act, the Commission specifies limits
for the radiological properties of what is
distributed to persons exempt from
licensing, and carefully oversees the
manufacture and distribution of the
approved products and materials.

As beneficial uses of byproduct
material were developed and experience
grew, new products intended for use by
the public were invented, and the
regulations were amended to
accommodate their use under various
exemptions from licensing. These
products and materials present very low
risks of significant individual doses.
However, a substantial portion of the
public uses these products\u2014more than
100 million smoke detectors are in use
in this country\u2014and as a result, is
routinely exposed to some ionizing
radiation. Therefore, in the 1990s, the
Commission conducted a systematic
reevaluation of the exempt materials
and products, most of which had been
approved before 1970. A major part of
the effort was an assessment of the
potential and likely doses to workers
and the public under the existing
regulations governing the distribution of
exempt products.

Dose assessments associated with
most exempt products can be found in
Radiological Assessment of Exemptions
for Source and Byproduct Materials,\u2019\u2019
June 2001. Generally, the systematic
assessment of exemptions determined
that no significant problems exist with
the current uses of byproduct materials
under the exemptions from licensing.
Actual exposures of the public likely to
occur are in line with Commission

policy concerning acceptable doses from
exempt products and materials. For
some exempt products, there was a
significant difference between potential
and likely doses because the use of the
exempt product is limited (or
nonexistent) or significantly lower
quantities are used in products than is
potentially allowed under the

The Commission is also revising a
certain general license within this final
rule. General licenses are provided by
regulation, grant authority to a person
for certain activities involving
byproduct material, and are effective
without the filing of an application with
the Commission or the issuance of
licensing documents to particular
persons. Separate and distinct from
either exemptions or specific licenses,
general licenses are designed to be
commensurate with the specific
circumstances covered by each general
license. However, the NRC has
determined that its regulations were not
clear with respect to certain transfers of
generally licensed devices. This has led
to inefficiencies in licensing oversight
and may negatively impact public
confidence. Thus, the NRC is clarifying
and simplifying its regulations related to
this issue.

This final rule reflects the
Commission\u2019s goals to make its
regulations more flexible, user-friendly,
and performance-based, and to improve
its ability to risk-inform its regulatory
program. These concepts continue to be
considered in developing potential
revisions to the regulatory program in
the area of distribution of byproduct
material to exempt persons. To make
optimal use of rulemaking resources,
both for the NRC and the States who
must develop conforming regulations,
several issues have been combined into
this final rule.

A proposed rule containing these
amendments was published for public
comment in the Federal Register on
January 4, 2006 (71 FR 275). The public
comment period closed March 20, 2006.
Nine comment letters were received.
The NRC has considered these
comments in this final rule.

B. Regulatory Framework

The Commission\u2019s regulations in Part
30 contain the basic requirements for
licensing of byproduct material. Part 30
includes a number of regulations that
exempt the end user from licensing
requirements, so-called\u2018\u2018exemptions.\u2019\u2019
Many of these exemptions are product-
specific, intended only for specific
purposes which are narrowly defined by
regulation. More broadly defined are the
general materials exemptions, which

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Federal Register/ Vol. 72, No. 199 / Tuesday, October 16, 2007 / Rules and Regulations

allow the use of many radionuclides in
many chemical and physical forms
subject to limits on activity, and which
are specified in\u00a7\u00a7 30.14 and 30.18 for
exempt concentrations and exempt
quantities, respectively. The
Commission\u2019s regulations also include
two class exemptions\u2014for self-
luminous products and gas and aerosol
detectors, in\u00a7\u00a7 30.19 and 30.20,
respectively\u2014which cover a broad class
of products not limited to certain
quantities or radionuclides. Under the
class exemptions, many products can be
approved for use through the licensing
process if the applicant demonstrates
that the specific product is within the
class and meets certain radiation dose

Part 31 provides general licenses for
the use of certain items containing
byproduct material and the
requirements associated with these
general licenses.

Part 32, Subpart A, sets out
requirements for the manufacture or
initial transfer (distribution) of items
containing byproduct material to
persons exempt from licensing

Part 150 sets out regulations for all
States that have entered into agreements
with the Commission under subsection
274b of the Act.

II. Discussion

This final rule makes a number of
revisions to the regulations governing
the use of byproduct material under
exemptions from licensing and under
general license, and to the requirements
for those who distribute products and
materials for use under exemptions from
licensing. The changes are intended to
better ensure the protection of public
health and safety and improve the
efficiency and effectiveness of certain
licensing actions.

A. Improved Reporting of Distribution to
Persons Exempt From Licensing

The reporting and recordkeeping
requirements for distributors of
products containing byproduct material
to persons exempt from licensing in Part
30 are being amended to improve the
quality of data available to the NRC. The
changes set forth in this rule have been
made in such a way that there is an
insignificant effect on these licensees\u2019
reporting and recordkeeping burdens.
The reporting and recordkeeping
requirements for these distributors are
found in\u00a7\u00a7 32.12, 32.16, 32.20, 32.25(c),
and 32.29(c).

Before 1983, reporting of transfers of
exempt byproduct material was required
on an annual basis. The NRC amended

its regulations in 1983 to change the
reporting requirement to once every 5
years to minimize administrative
burden. The 1983 reporting regulations
required that an additional materials
transfer report be submitted when filing
for license renewal or notifying the NRC
of a decision to cease licensed activities.
However, subsequent experience with
the 5-year reporting frequency has
shown that it does not provide the NRC
with complete, accurate, or timely
information on products and materials
containing byproduct material
distributed for use under exemptions
from licensing.

A 5-year reporting cycle does not
produce timely information for the NRC
to fully determine the products and
amount of byproduct material
distributed annually for exempt use.
The lack of timely information limits
the NRC\u2019s ability to evaluate the overall
net impact of such distribution on
public health and safety. Because the
date of reporting for each licensee is
different and the information is not
necessarily reported by year, it is
difficult to estimate the amount or types
of exempt products containing
byproduct material distributed each
year or to detect emerging trends. A 5-
year reporting period also negatively
affects the availability of current
information. The limitations of the
information about the products and
materials and quantities distributed for
use under exemption greatly impacted
the effort involved in developing the
dose assessments in NUREG\u20131717 and
contributed to uncertainties in the

Reevaluation of the reporting
requirements suggests that annual
reporting may also be administratively
more efficient than a 5-year cycle for
both the NRC and licensees. There have
been more implementation problems
with the longer cycle than with annual
reporting. For example, because of the
long interval between reports, licensees
frequently neglect to file reports in
compliance with the regulations. This
lapse sometimes results in the need for
the NRC to request that additional
information be sent so that an
application for renewal or termination
of license can be processed. The long
interval between reports also may lead
to licensee inefficiencies in collecting
the data. Routine annual reporting
should be more straightforward and
easier for licensees to comply with than
consolidating and reporting 5 years of
distribution information.

This final rule requires that material
transfer reports covering transfers made
during the calendar year be submitted
annually by January 31 of the following

year. In the first report made after the
change, licensees are being required to
submit information on transfers made
since the previous report, so that there
are no gaps in coverage. The
requirements added in 1983 for
licensees to file a special material
transfer report when filing for license
renewal (contained in the existing

\u00a7\u00a732.12, 32.16, 32.20, 32.25, and 32.29)

are being deleted. Another change is
being made to the same sections so that
material transfer reports are required 30
days after ceasing authorized activities,
rather than at the point of notifying the
Commission of the decision to cease
authorized activities.

In addition to the lengthy period
between the 5-year reports, the manner
in which product information and
licensee information has been submitted
in the reports has not always been clear,
making the data more difficult to use.
This final rule modifies how
information is to be provided,
improving clarity by making the
reporting provisions more specific.
Under the revised provisions, as
specified in\u00a7\u00a7 32.12(a)(1), 32.16(a)(1),
32.20(b)(1), 32.25(c)(1), and 32.29(c)(1),
the report must clearly identify the
specific licensee submitting the report,
including the license number. In
addition, as specified in\u00a7\u00a7 32.12(a)(2),
32.16(a)(2), 32.20(b)(2), 32.25(c)(2), and
32.29(c)(2), the report is required to
reference the specific exemption
provision under which the products or
materials are being distributed.

The current regulations require that
the licensee must identify the
distributed product; however, different
licensees have complied with this
requirement in a number of ways, some
of which necessitated that the NRC
obtain additional information to fully
interpret what was being distributed.
Licensees have frequently included
model numbers in the reports, but often
as the only identification of the type of
product being transferred. This final
rule adds the requirement to report
model numbers, when applicable, as
part of the required information.

Other changes are being made to
reduce the licensees\u2019 reporting and
recordkeeping burden. Under the prior
framework, licensees were required to
send a copy of the transfer reports to
both the NRC headquarters and the
appropriate Regional office. The
requirement to send a copy of the
reports to the Regional offices will be
removed. Instead, the information will
be distributed by the NRC internally to
the appropriate personnel. To make the
NRC\u2019s internal document handling more
efficient, the address to which reports
are to be sent will contain the line,

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